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    Clinical Trial Results:
    A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis

    Summary
    EudraCT number
    		 2016-003361-25
    Trial protocol
    		 DE   EE   HU   ES   PL   AT   FR   GB   IT  
    Global end of trial date
    01 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Apr 2019
    First version publication date
    10 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SHP640-303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03004924
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Shire
    Sponsor organisation address
    300 Shire Way, Lexington, United States, MA 02421
    Public contact
    Study Director, Shire, ClinicalTransparency@shire.com
    Scientific contact
    Study Director, Shire, ClinicalTransparency@shire.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001936-PIP01-16
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of SHP640 based on clinical resolution (defined as absence of bulbar conjunctival injection and ocular conjunctival discharge) compared with placebo in the treatment of subjects with bacterial conjunctivitis in the study eye on Day 5.
    Protection of trial subjects
    The study was conducted in accordance with applicable regulations, International Conference on Harmonisation (ICH), European Union (EU) Directive 2001/20/EC and its updates, and local ethical and legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Mar 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Austria: 14
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Estonia: 21
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Israel: 14
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Puerto Rico: 11
    Country: Number of subjects enrolled
    South Africa: 18
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 640
    Worldwide total number of subjects
    753
    EEA total number of subjects
    60
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    10
    Children (2-11 years)
    66
    Adolescents (12-17 years)
    27
    Adults (18-64 years)
    482
    From 65 to 84 years
    158
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at 121 centers in 14 countries between 29 Mar 2017 (first subject first visit) and 01 Oct 2018 (last subject last visit).

    Pre-assignment
    Screening details
    		 A total of 1080 subjects were screened, of them 753 were randomized to treatment. One subject was randomized in error and therefore captured only in the intent-to-treat (ITT) population.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SHP640
    Arm description
    		 Subjects administered 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times a day (QID) for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SHP640
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    Subjects administered 1 drop of SHP640 ophthalmic suspension in each eye QID.

    Arm title
    		 PVP-I 0.6%
    Arm description
    		 Subjects administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PVP-I
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    Subjects administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID.

    Arm title
    		 Placebo
    Arm description
    		 Subjects administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    Subjects administered 1 drop of placebo ophthalmic solution in each eye QID.

    Number of subjects in period 1
    		SHP640 PVP-I 0.6% Placebo
    Started
    324
    108
    321
    Completed
    297
    94
    293
    Not completed
    27
    14
    28
         Terminated by Sponsor
    -
    -
    1
         Missed Study Visit
    -
    -
    2
         Consent withdrawn by subject
    5
    3
    5
         Physician decision
    1
    -
    1
         Screen Failure
    1
    -
    -
         Adverse event, non-fatal
    6
    5
    10
         HSV1 Positive
    1
    -
    -
         Pregnancy
    -
    1
    -
         Lost to follow-up
    6
    1
    4
         Withdrawal by parent/guardian
    1
    -
    2
         Protocol deviation
    4
    -
    1
         Lack of efficacy
    2
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SHP640
    Reporting group description
    		 Subjects administered 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times a day (QID) for 7 days.

    Reporting group title
    PVP-I 0.6%
    Reporting group description
    		 Subjects administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.

    Reporting group values
    		 SHP640 PVP-I 0.6% Placebo Total
    Number of subjects
    		 324 108 321
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.2 ( 22.87 ) 43.1 ( 23.03 ) 44.7 ( 23.00 ) -
    Gender categorical
    Units: Subjects
        Female
    		 191 71 199 461
        Male
    		 133 37 122 292
    Race/Ethnicity, Customized
    Units: Subjects
        Ethnicity Hispanic or Latino
    		 62 30 87 179
        Ethnicity Not Hispanic or Latino
    		 254 76 230 560
        Ethnicity Not reported
    		 4 2 2 8
        Ethnicity Other
    		 4 0 2 6
    Race/Ethnicity, Customized
    Units: Subjects
        Race American Indian or Alaska Native
    		 0 1 3 4
        Race Asian
    		 12 0 8 20
        Race Black or African American
    		 54 18 54 126
        Race White
    		 250 88 250 588
        Race Native Hawaiian or Other Pacific Islander
    		 0 0 2 2
        Race Other
    		 6 1 4 11
        Race Multiple
    		 2 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    SHP640
    Reporting group description
    		 Subjects administered 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times a day (QID) for 7 days.

    Reporting group title
    PVP-I 0.6%
    Reporting group description
    		 Subjects administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.

    Primary: Number of Subjects With Clinical Resolution Among who Received SHP640 or Placebo on Day 5

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    End point title
    		 Number of Subjects With Clinical Resolution Among who Received SHP640 or Placebo on Day 5 [1]
    End point description
    Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern)-4(Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva)-3 (Abundant quantity of mucopurulent or purulent discharge) scale. Study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Modified intent-to-treat (mITT) population included subjects who received at least one dose of investigational product and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline. Here, number of subjects analyzed refer to evaluable subjects at specified time points.
    End point type
    Primary
    End point timeframe
    Day 5
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to compare the efficacy between the SHP640 and placebo groups.
    End point values
    		 SHP640 Placebo
    Number of subjects analysed
    220
    222
    Units: Subjects
        Subjects
    111
    95
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v SHP640
    Number of subjects included in analysis
    442
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.127
    Method
    		 Fisher exact
    Parameter type
    		 Difference in response rate
    Point estimate
    7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 16.9

    Secondary: Number of Subjects With Bacterial Eradication Among who Received SHP640 or Placebo on Day 5

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    End point title
    		 Number of Subjects With Bacterial Eradication Among who Received SHP640 or Placebo on Day 5 [2]
    End point description
    Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each subject. mITT population included subjects who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of subjects analyzed refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 5
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to compare the efficacy between the SHP640 and placebo groups.
    End point values
    		 SHP640 Placebo
    Number of subjects analysed
    217
    218
    Units: Subjects
        Subjects
    94
    102
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v SHP640
    Number of subjects included in analysis
    435
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5
    Method
    		 Fisher exact
    Parameter type
    		 Difference in response rate
    Point estimate
    -3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.8
         upper limit
    		 5.9

    Secondary: Number of Subjects With Clinical Resolution

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    End point title
    		 Number of Subjects With Clinical Resolution
    End point description
    Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4(Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva)-3 (Abundant quantity of mucopurulent or purulent discharge) scale. Study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. mITT population included subjects who received at least one dose of investigational product and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline. in the study. Here, "n" refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Day 3, 8 and 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    223
    76
    227
    Units: Subjects
        Day 3 (n=215,76,218)
    39
    6
    39
        Day 8 (n=205,65,206)
    148
    39
    133
        Day 12 (n=195,62,187)
    150
    47
    154
    No statistical analyses for this end point

    Secondary: Number of Subjects With Bacterial Eradication

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    End point title
    		 Number of Subjects With Bacterial Eradication
    End point description
    Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each subject. mITT population included subjects who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, "n" refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Day 3, 8 and 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    223
    76
    227
    Units: Subjects
        Day 3 (n=213,75,214)
    76
    33
    79
        Day 8 (n=205,64,200)
    85
    25
    87
        Day 12 (n=194,60,183)
    83
    21
    82
    No statistical analyses for this end point

    Secondary: Bulbar Conjunctival Injection Score

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    End point title
    		 Bulbar Conjunctival Injection Score
    End point description
    Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. mITT population included subjects who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, "n" refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Day 3, 5, 8 and 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    223
    76
    227
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 3 (n=216,76,218)
    1.0 ( 0.84 )
    1.3 ( 0.90 )
    1.1 ( 0.86 )
        Day 5 (n=207,65,209)
    0.5 ( 0.77 )
    0.7 ( 0.88 )
    0.7 ( 0.80 )
        Day 8 (n=205,65,206)
    0.3 ( 0.64 )
    0.4 ( 0.61 )
    0.4 ( 0.61 )
        Day 12 (n=196,62,187)
    0.2 ( 0.56 )
    0.2 ( 0.47 )
    0.2 ( 0.48 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Bulbar Conjunctival Injection Score

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    End point title
    		 Change From Baseline in the Bulbar Conjunctival Injection Score
    End point description
    Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. mITT population included subjects who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, "n" refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 3, 5, 8 and 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    223
    76
    227
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 3 (n=216,76,218)
    -1.0 ( 0.77 )
    -0.8 ( 0.76 )
    -0.9 ( 0.76 )
        Day 5 (n=207,65,209)
    -1.5 ( 0.87 )
    -1.3 ( 0.99 )
    -1.3 ( 0.85 )
        Day 8 (n=205,65,206)
    -1.8 ( 0.91 )
    -1.6 ( 0.86 )
    -1.6 ( 0.81 )
        Day 12 (n=196,62,187)
    -1.8 ( 0.89 )
    -1.8 ( 0.74 )
    -1.8 ( 0.82 )
    No statistical analyses for this end point

    Secondary: Ocular Conjunctival Discharge Score

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    End point title
    		 Ocular Conjunctival Discharge Score
    End point description
    Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. mITT population included subjects who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, "n" refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Day 3, 5, 8 and 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    223
    76
    227
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 3 (n=215,76,218)
    0.7 ( 0.73 )
    0.8 ( 0.74 )
    0.7 ( 0.76 )
        Day 5 (n=206,65,209)
    0.3 ( 0.57 )
    0.2 ( 0.44 )
    0.4 ( 0.60 )
        Day 8 (n=205,65,206)
    0.1 ( 0.43 )
    0.1 ( 0.31 )
    0.2 ( 0.47 )
        Day 12 (n=195,62,187)
    0.1 ( 0.49 )
    0.0 ( 0.22 )
    0.1 ( 0.28 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Ocular Conjunctival Discharge Score

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    End point title
    		 Change From Baseline in the Ocular Conjunctival Discharge Score
    End point description
    Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. mITT population included subjects who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, "n" refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 3, 5, 8 and 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    223
    76
    227
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 3 (n=215,76,218)
    -0.9 ( 0.77 )
    -0.8 ( 0.67 )
    -0.9 ( 0.85 )
        Day 5 (n=206,65,209)
    -1.4 ( 0.74 )
    -1.4 ( 0.75 )
    -1.3 ( 0.75 )
        Day 8 (n=205,65,206)
    -1.5 ( 0.71 )
    -1.5 ( 0.73 )
    -1.4 ( 0.74 )
        Day 12 (n=195,62,187)
    -1.5 ( 0.76 )
    -1.6 ( 0.71 )
    -1.6 ( 0.73 )
    No statistical analyses for this end point

    Secondary: Global Clinical Score

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    End point title
    		 Global Clinical Score
    End point description
    Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. mITT population included subjects who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, "n" refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Day 3, 5, 8 and 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    223
    76
    227
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 3 (n=215,76,218)
    1.7 ( 1.37 )
    2.1 ( 1.39 )
    1.9 ( 1.42 )
        Day 5 (n=206,65,209)
    0.8 ( 1.18 )
    0.9 ( 1.19 )
    1.0 ( 1.18 )
        Day 8 (n=205,65,206)
    0.4 ( 0.93 )
    0.5 ( 0.77 )
    0.6 ( 0.93 )
        Day 12 (n=195,62,187)
    0.4 ( 0.90 )
    0.3 ( 0.55 )
    0.3 ( 0.67 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Global Clinical Score

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    End point title
    		 Change From Baseline in the Global Clinical Score
    End point description
    Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. mITT population included subjects who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, "n" refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 3, 5, 8 and 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    223
    76
    227
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 3 (n=215,76,218)
    -1.9 ( 1.28 )
    -1.6 ( 1.22 )
    -1.8 ( 1.30 )
        Day 5 (n=206,65,209)
    -2.9 ( 1.27 )
    -2.8 ( 1.47 )
    -2.6 ( 1.31 )
        Day 8 (n=205,65,206)
    -3.2 ( 1.36 )
    -3.2 ( 1.25 )
    -3.1 ( 1.25 )
        Day 12 (n=195,62,187)
    -3.3 ( 1.38 )
    -3.4 ( 1.06 )
    -3.3 ( 1.23 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Modified Clinical Resolution

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    End point title
    		 Number of Subjects With Modified Clinical Resolution
    End point description
    Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. mITT population included subjects who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, "n" refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Day 3, 5, 8 and 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    223
    76
    227
    Units: Subjects
        Day 3 (n=215,76,218)
    100
    28
    93
        Day 5 (n=206,65,209)
    166
    48
    143
        Day 8 (n=205,65,206)
    189
    59
    175
        Day 12 (n=195,62,187)
    182
    59
    173
    No statistical analyses for this end point

    Secondary: Number of Subjects With Expanded Clinical Resolution

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    End point title
    		 Number of Subjects With Expanded Clinical Resolution
    End point description
    Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. mITT population included subjects who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, "n" refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Day 3, 5, 8 and 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    226
    76
    227
    Units: Subjects
        Day 3 (n=215,76,218)
    155
    46
    154
        Day 5 (n=206,65,209)
    185
    54
    171
        Day 8 (n=205,65,206)
    193
    63
    192
        Day 12 (n=195,62,187)
    185
    61
    181
    No statistical analyses for this end point

    Secondary: Time to Clinical Resolution

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    End point title
    		 Time to Clinical Resolution
    End point description
    Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a subject first reached clinical resolution minus the date of first dose of investigational product, plus 1. mITT population included subjects who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    223
    76
    227
    Units: Days
    median (confidence interval 95%)
        Days
    5 (5.0 to 8.0)
    6 (5.0 to 8.0)
    8 (5.0 to 8.0)
    No statistical analyses for this end point

    Secondary: Number of Subjects who Used Rescue Medication

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    End point title
    		 Number of Subjects who Used Rescue Medication
    End point description
    Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons. mITT population included subjects who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    223
    76
    227
    Units: Subjects
        Subjects
    2
    3
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Subjects with Treatment-emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE. Safety population included all subjects who received at least one dose of investigational product.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 14 days
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    323
    108
    321
    Units: Subjects
        Subjects
    106
    43
    61
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study drug administration up to 14 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    SHP640
    Reporting group description
    		 Subjects administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.

    Reporting group title
    PVP-I 0.6%
    Reporting group description
    		 Subjects administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.

    Serious adverse events
    		 SHP640 Placebo PVP-I 0.6%
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 321 (0.00%)
    0 / 108 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SHP640 Placebo PVP-I 0.6%
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 323 (20.74%)
    7 / 321 (2.18%)
    26 / 108 (24.07%)
    General disorders and administration site conditions
    Instillation site pain
         subjects affected / exposed
    67 / 323 (20.74%)
    7 / 321 (2.18%)
    26 / 108 (24.07%)
         occurrences all number
    68
    7
    26

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Nov 2016
    Aligned clinical strategy and language across the SHP640 adenoviral and bacterial conjunctivitis programs and updated the assessments and inclusion and exclusion criteria.
    15 Feb 2017
    - Added the Middle East and Africa to the list of regions participating in the study. - Added the discontinuation of subjects less than 2 months old who tested positive for the presence of chlamydia or gonorrhea. - Added the discontinuation of subjects who tested positive for HSV in either eye at baseline and added testing for HSV by qPCR in all subjects at baseline.
    13 Dec 2017
    - Added windows for Study Visit 2, 4, and 5, and changed the window for the inclusion criterion relating to bacterial conjunctivitis. - Clarified the exclusion criterion relating to a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis. - Removed the exclusion criterion relating to subjects with a known history of elevated intraocular pressure >21 mmHg. - Clarified the safety follow up to be conducted for subjects who tested positive for HSV in either eye.
    31 Jul 2018
    - Increased the planned number of subjects to be randomized and the number of study sites, to ensure the target number of subjects in the mITT population would be achieved.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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